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  5. Label Information: Aspirin

FDA Label for Aspirin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH TABLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. ALCOHOL WARNING:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(In Each Tablet)



Aspirin 325mg


Purposes



Pain reliever/fever reducer


Uses



temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • minor pain of arthritis
  • pain and fever of colds

Warnings



Reye's syndrome:Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert:Aspirin may cause a severe allergic reaction which may include:
  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

Alcohol Warning:



If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain reliever/fever reducers. Aspirin may cause stomach bleeding.


Do Not Use



if you are allergic to aspirin or any other pain reliever/fever reducer


Ask A Doctor Before Use If You Have



  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug for

  • anticoagulation (blood thinning)
  • gout
  • diabetes
  • arthritis

Stop Use And Ask A Doctor If



  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • ringing in the ears or loss of hearing occurs

If Pregnant Or Breast-Feeding,



ask a health professional before use.It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
  • children under 12 years: consult a doctor

Other Information



  • save carton for full directions and warnings
  • store at room temperature

Inactive Ingredients



dry starch, citric acid, carboxymethyl starch sodium, starch, starch paste


Package Label.Principal Display Panel



Aspirin

image of bottle label - aspirin.carton

image of bottle label - aspirin.carton


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